NCT02287532已完成不适用
Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète191 个研究点 分布在 1 个国家目标入组 667 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 667
- 试验地点
- 191
- 主要终点
- Efficacy data: change in HbA1c, measured at 1 year minus the value baseline
研究概览
简要总结
The aim of the TELESAGE study is to demonstrate
- the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.
- the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.
The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system.
The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetic patients
- •Performing auto-glycaemic control (at least 2 glycemias a day)
- •Treated with insulin by a basal-bolus regimen for at least 1 year and using the same method of administration for at least 3 months (insulin pen or pump)
- •Who have an Apple® or Androïde® Smartphone compatible, or intend to acquire one before their participation in the study
- •Whose HbA1c dating of less 1 month and more than 3 months is ≥ 8%
- •Who are able to understand and follow the study protocol
- •Who have given their signed consent to take part in the study
- •Subject affiliated to the French National Health Insurance funds or benefiting from such insurance
排除标准
- •Age < 18 years old
- •Patients who have used the DIABEO system within 6 months before inclusion
- •Participation in a clinical study within 6 months, except for the Meos (or télédiab 3) study after a participation period of 6 months
- •Patients who are pregnant or who wish to become pregnant during the study.
- •Patients treated with human insulin A patient pre-screening register will be set up in each centre to establish the reasons for DM1/DM2 patients treated with a basal-bolus insulin regimen who are not taking part in the study.
结局指标
主要结局
Efficacy data: change in HbA1c, measured at 1 year minus the value baseline
时间窗: one year
次要结局
未报告次要终点
研究者
Sylvia Franc
Dr Sylvia Franc, MD, VP, scientific affairs
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
研究点 (191)
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